NCT05242237

Prognostic Value of Liver Cancer CTCs Isolated by a Novel Microfluidic Platform

Status unknown Last updated 16 February 2022

What this trial tests

trial in Hepatocellular Carcinoma in 300 participants. Status unknown.

Timeline

1 December 2021

Primary endpoint
31 January 2024

31 January 2024

Quick facts

Lead sponsor	The Second Affiliated Hospital of Chongqing Medical University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 December 2021
Primary completion	31 January 2024
Estimated completion	31 January 2024
Sites	1 location across China

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
• Circulating Tumor Cell — all drugs for Circulating Tumor Cell →
• Whole Genome Sequencing — all drugs for Whole Genome Sequencing →

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Who can join

Adults 18 to 70, any sex, with Hepatocellular Carcinoma or Circulating Tumor Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to isolate CTCs in peripheral venous blood of liver cancer patients by inertial focusing principle-based microfluidic device, determine the relationship between the number of CTCs and patient prognosis and treatment response, detect mutation, copy number variation and mutation load in CTC cells and corresponding tissues using single-cell whole genome sequencing technology, and use bioinformatics analysis of CTC heterogeneity and its relationship with clinical outcome. In addition, the culture of CTCs in vitro was explored by organoid culture or sphere culture in order to obtain CTCs cell lines to reveal the metastatic mechanisms of HCC. The partner of this project is Cellomics International Limited, which could provide Cellomics CTC-100 cell sorter and related consumables for this project. Peripheral venous blood from about 300 patients with initial liver cancer will be collected, and CTCs cells will be sorted in 8ml of each patient and typed according to protein expression. Clinical data, treatment effect and survival time of patients will be collected, and finally the relationship between the number of CTCs and subgroup with treatment response and patient prognosis will be analyzed. Uncovering the genomic characteristics of CTCs of HCC provides a new basis for the precise treatment of HCC. The new diagnostic markers for Hcancer were found by miRNA expression spectrum chip and metabolomic testing.In vitro culture methods and cellular characteristics of HCC circulating tumor cells were preliminarily explored.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Liquid Biopsy in Hepatocellular Carcinoma: The Significance of Circulating Tumor Cells in Diagnosis, Prognosis, and Treatment Monitoring.
   Shaik MR, Sagar PR, Shaik NA, Randhawa N. · · 2023 · cited 13× · PMID 37445822 · DOI 10.3390/ijms241310644
2. Single-Circulating Tumor Cell Whole Genome Amplification to Unravel Cancer Heterogeneity and Actionable Biomarkers.
   Khan T, Becker TM, Po JW, Chua W, et al · · 2022 · cited 13× · PMID 35955517 · DOI 10.3390/ijms23158386
3. Current Applications of Liquid Biopsy in Gastrointestinal Cancer Disease-From Early Cancer Detection to Individualized Cancer Treatment.
   David P, Mittelstädt A, Kouhestani D, Anthuber A, et al · · 2023 · cited 10× · PMID 37046585 · DOI 10.3390/cancers15071924
4. Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
   Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y
5. Current status and perspectives of genetic testing in gastrointestinal cancer (Review).
   Matsuoka T, Yashiro M. · · 2024 · cited 4× · PMID 38058469 · DOI 10.3892/ol.2023.14155
6. Organoid as a promising tool for primary liver cancer research: a comprehensive review.
   Hu X, Wei J, Liu P, Zheng Q, et al · · 2024 · cited 3× · PMID 39192365 · DOI 10.1186/s13578-024-01287-5
7. Harnessing induced pluripotent stem cells and organoids for disease modeling and precision medicine.
   Lee CJ, Nam Y, Rim YA, Ju JH. · · 2026 · PMID 41656303 · DOI 10.1186/s13287-026-04906-9